TAVR in 2023: Who Should Not Get It?

https://doi.org/10.1016/j.amjcard.2023.01.040Get rights and content

Since the first transcatheter delivery of an aortic valve prosthesis was performed by Cribier et al in 2002, the picture of aortic stenosis (AS) therapeutics has changed dramatically. Initiated from an indication of inoperable to high surgical risk, extending to intermediate and low risk, transcatheter aortic valve replacement (TAVR) is now an approved treatment for patients with severe, symptomatic AS across all the risk categories. The current evidence supports TAVR as a frontline therapy for treating severe AS. The crucial question remains concerning the subset of patients who still are not ideal candidates for TAVR because of certain inherent anatomic, nonmodifiable, and procedure-specific factors. Therefore, in this study, we focus on these scenarios and reasons for referring selected patients for surgical aortic valve replacement in 2023.

Section snippets

Evolution of TAVR: From Prohibitive- to Low-Risk Cohort

The first THV designed by Cribier et al1 was a stainless-steel stent (23 mm in diameter and 17 mm in height) containing a trileaflet valve made of bovine pericardium, compatible with a 24-French (F) introducer sheath, and was implanted using anterograde transseptal approach. Since then, there has been substantial refinement in the design of both THVs and delivery systems, transforming what was a challenging intervention into a standardized, streamlined procedure. The first landmark randomized

Bicuspid Aortic Valve

BAV can be associated with AS (12% to 37%), AR (13% to 30%), or both. Furthermore, involvement of the aorta leads to aortic dilatation in 20% to 40% of cases.12 In 2019, the Food and Drug Administration approved TAVR for patients at low risk regardless of valve morphology, even though patients with BAV were excluded from the randomized cohorts of the pivotal trials.2,3 To date, there remain no randomized data comparing TAVR with surgery in patients with BAV, and the available data are primarily

Unicuspid Aortic Valve

Unicuspid aortic valve (Figure 3) is a rare congenital disease with an estimated incidence of 5%.23 Isolated AS (7%) is an uncommon presentation; most patients (93%) present with mixed AS and AR at the time of diagnosis.24 As with patients with BAV, management of patients with unicuspid aortic valve is challenging because most present at a young age and commonly have associated aortic pathologies. Data from the Mayo Clinic registry suggest successful AVR in these patients, with mechanical (61%)

Large aortic annulus

Anatomic factors such as aortic annulus size significantly affect TAVR device success and long-term hemodynamic performance. Appropriate valve sizing using multidetector computed tomography (CT) is critical to lessen the incidence of PVL and life-threatening complications such as annulus rupture and valve embolization, especially in patients with large aortic annuli, defined as area ≥575 mm2 or perimeter ≥85.0 mm measured in systole (Figure 4), and extra-large aortic annuli (aortic annulus area

Vascular access

Transfemoral access is the preferred route for TAVR in most cases.48 Despite improvement in device technology and smaller delivery sheath profiles, vascular complications remain relevant, with reported incidences of 10% to 20%.49 The key risk factors include older age, female gender, obesity, peripheral vascular disease, calcification, and significant tortuosity of iliofemoral vessels.50 Because vascular complications are an independent predictor of morbidity and mortality, careful procedural

Young Patients

One of the key limitations of bioprostheses (surgical or transcatheter) is their long-term durability, particularly in younger patients, who have longer life expectancy and are therefore more likely to need repeat valve interventions. Because the initial TAVR studies included mostly octogenarians who were inoperable and at high risk, serial follow-up for identification of late valve dysfunction was not possible because subjects died from other causes long before their valves degenerated.6 The

Atrial fibrillation

The presence of valvular disease is considered an independent risk factor for AF.75 The prevalence of AF increases with age similarly to that of AS and is found in >9.0% of subjects aged >80 years.76 AF is observed in up to one-third of patients who undergo TAVR and has been associated with worse outcomes, with increased risk of all-cause and cardiovascular mortality.77 Most patients with nonvalvular AF end up on non–VKA oral anticoagulants these days because of the improved lifestyle and

Aortic Regurgitation

The most common causes of chronic severe AR are BAV and diseases of the ascending aorta and sinuses of Valsalva. Pure AR is also far less prevalent than AS (10% vs 34%).102 Previous studies with “off-label” use of TAVR to treat pure native AR with older-generation THVs found higher rates of embolization and migration and significant risk of PVL.103 Only a few reports have successfully shown that THV implantation using a less invasive approach is feasible104; however, this demands careful

Conduction Abnormalities

One of the key apprehensions after TAVR is an increased risk of conduction abnormalities because of increased forces on the atrioventricular valve and His’ bundle, leading to worsening of preexisting conduction disease or complete heart block and necessitating permanent pacemaker implantation (Figure 8). The overall clinical impact of pacemaker implantation is controversial; however, studies have shown its association with lengthier hospital stay107 and increased risk of all-cause death and

Future Directions

The expansion of TAVR to patients at low and intermediate risk will eventually provide an answer to the paramount question of long-term prosthesis durability. Future research should focus on comparing TAVR with surgery to address remaining unanswered questions such as which intervention is better for patients in the middle age range (51 to 69 years), for patients with moderate AS or asymptomatic severe AS, and for patients with multivalvular disease. Another key area to explore for TAVR is

Conclusions

Undoubtedly, there has been a paradigm shift in the treatment of AS from SAVR to TAVR over the last decade, which will certainly continue in 2023 and beyond. Refinement of procedural technique and THV technology, along with the accumulation of new data, will expand TAVR indications even further. Nonetheless, there remain many anatomic and clinical scenarios in which SAVR is a better strategy. In 2023, a heart team approach, shared decision-making, patient preference, the weighing of procedural

Disclosures

Dr. Reardon is a consultant for Medtronic, Boston Scientific, Abbott Medical, and Gore Medical.

Steven J. Yakubov is a consultant for Medtronic, Boston Scientific, and Foldax.

Dr. Rogers reports being a proctor and consultant for Boston Scientific, Edwards Lifesciences, and Medtronic; serving on the Advisory Board of Medtronic; and holding equity interest in Transmural Systems Inc.

Dr. Waksman reports serving on the advisory boards of Abbott Vascular, Boston Scientific, Medtronic, Philips IGT, and

References (116)

  • PP Leone et al.

    Predictors and clinical impact of prosthesis-patient mismatch after self-expandable TAVR in small annuli

    JACC Cardiovasc Interv

    (2021)
  • F Bakhtiary et al.

    Impact of patient-prosthesis mismatch and aortic valve design on coronary flow reserve after aortic valve replacement

    J Am Coll Cardiol

    (2007)
  • HC Herrmann et al.

    Prosthesis-patient mismatch in patients undergoing transcatheter aortic valve replacement: from the STS/ACC TVT Registry

    J Am Coll Cardiol

    (2018)
  • GHL Tang et al.

    Outcomes of prosthesis-patient mismatch following supra-annular transcatheter aortic valve replacement: from the STS/ACC TVT Registry

    JACC Cardiovasc Interv

    (2021)
  • SA Daneshvar et al.

    Valve prosthesis-patient mismatch (VP-PM): a long-term perspective

    J Am Coll Cardiol

    (2012)
  • HC Herrmann et al.

    Rationale and design of the SMall Annuli Randomized to Evolut or SAPIEN Trial (SMART trial)

    Am Heart J

    (2022)
  • Y Maeno et al.

    Relation between left ventricular outflow tract calcium and mortality following transcatheter aortic valve implantation

    Am J Cardiol

    (2017)
  • SR Kapadia et al.

    Protection against cerebral embolism during transcatheter aortic valve replacement

    J Am Coll Cardiol

    (2017)
  • S Toggweiler et al.

    Percutaneous aortic valve replacement: vascular outcomes with a fully percutaneous procedure

    J Am Coll Cardiol

    (2012)
  • RJ Lederman et al.

    Transcaval versus transaxillary TAVR in contemporary practice: a propensity-weighted analysis

    JACC Cardiovasc Interv

    (2022)
  • HB Ribeiro et al.

    Predictive factors, management, and clinical outcomes of coronary obstruction following transcatheter aortic valve implantation: insights from a large multicenter registry

    J Am Coll Cardiol

    (2013)
  • HB Ribeiro et al.

    Coronary obstruction following transcatheter aortic valve implantation: a systematic review

    JACC Cardiovasc Interv

    (2013)
  • JM Khan et al.

    The BASILICA Trial: prospective multicenter investigation of intentional leaflet laceration to prevent TAVR coronary obstruction

    JACC Cardiovasc Interv

    (2019)
  • T Palmerini et al.

    Coronary protection to prevent coronary obstruction during TAVR: a multicenter international registry

    JACC Cardiovasc Interv

    (2020)
  • GHL Tang et al.

    Alignment of transcatheter aortic-valve neo-commissures (ALIGN TAVR): impact on final valve orientation and coronary artery overlap

    JACC Cardiovasc Interv

    (2020)
  • T Rogers et al.

    Feasibility of coronary access and aortic valve reintervention in low-risk TAVR patients

    JACC Cardiovasc Interv

    (2020)
  • A Redondo et al.

    Commissural versus coronary optimized alignment during transcatheter aortic valve replacement

    JACC Cardiovasc Interv

    (2022)
  • DJ Blackman et al.

    Long-term durability of transcatheter aortic valve prostheses

    J Am Coll Cardiol

    (2019)
  • L Søndergaard et al.

    Durability of transcatheter and surgical bioprosthetic aortic valves in patients at lower surgical risk

    J Am Coll Cardiol

    (2019)
  • A Mazine et al.

    Ross procedure in adults for cardiologists and cardiac surgeons: JACC state-of-the-art review

    J Am Coll Cardiol

    (2018)
  • V Chan et al.

    Performance of bioprostheses and mechanical prostheses assessed by composites of valve-related complications to 15 years after aortic valve replacement

    J Thorac Cardiovasc Surg

    (2006)
  • P Stassano et al.

    Aortic valve replacement: a prospective randomized evaluation of mechanical versus biological valves in patients ages 55 to 70 years

    J Am Coll Cardiol

    (2009)
  • T Kaneko et al.

    Mechanical versus bioprosthetic mitral valve replacement in patients <65 years old

    J Thorac Cardiovasc Surg

    (2014)
  • A Weber et al.

    Ten-year comparison of pericardial tissue valves versus mechanical prostheses for aortic valve replacement in patients younger than 60 years of age

    J Thorac Cardiovasc Surg

    (2012)
  • O Lund et al.

    The influence of coronary artery disease and bypass grafting on early and late survival after valve replacement for aortic stenosis

    J Thorac Cardiovasc Surg

    (1990)
  • G Witberg et al.

    The prognostic effects of coronary disease severity and completeness of revascularization on mortality in patients undergoing transcatheter aortic valve replacement

    JACC Cardiovasc Interv

    (2017)
  • FW Mohr et al.

    Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical syntax trial

    Lancet

    (2013)
  • A Sannino et al.

    Meta-analysis of mortality outcomes and mitral regurgitation evolution in 4,839 patients having transcatheter aortic valve implantation for severe aortic stenosis

    Am J Cardiol

    (2014)
  • FH. Edwards

    The sts database at 20 years: a tribute to Dr Richard E. Clark

    Ann Thorac Surg

    (2010)
  • H MacVaugh et al.

    Unusual complications during mitral valve replacement in the presence of calcification of the annulus

    Ann Thorac Surg

    (1971)
  • HM Lak et al.

    Comparison of outcomes of transcatheter aortic valve implantation in patients with versus without mitral annular calcium

    Am J Cardiol

    (2022)
  • Z Rozenbaum et al.

    Aortic stenosis with severe tricuspid regurgitation: comparative study between conservative transcatheter aortic valve replacement and surgical aortic valve replacement combined with tricuspid repair

    J Am Soc Echocardiogr

    (2018)
  • A Cribier et al.

    Percutaneous transcatheter implantation of an aortic valve prosthesis for calcific aortic stenosis: first human case description

    Circulation

    (2002)
  • MJ Mack et al.

    Transcatheter aortic-valve replacement with a balloon-expandable valve in low-risk patients

    N Engl J Med

    (2019)
  • JJ Popma et al.

    Transcatheter aortic-valve replacement with a self-expanding valve in low-risk patients

    N Engl J Med

    (2019)
  • RR Makkar et al.

    Transcatheter aortic-valve replacement for inoperable severe aortic stenosis

    N Engl J Med

    (2012)
  • MB Leon et al.

    Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery

    N Engl J Med

    (2010)
  • CR Smith et al.

    Transcatheter versus surgical aortic-valve replacement in high-risk patients

    N Engl J Med

    (2011)
  • RA Nishimura et al.

    2014 AHA/ACC guideline for the management of patients with valvular heart disease: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines

    Circulation

    (2014)
  • MB Leon et al.

    PARTNER 2 Investigators. Transcatheter or surgical aortic-valve replacement in intermediate-risk patients

    N Engl J Med

    (2016)
  • Cited by (3)

    Funding: none.

    View full text